- Daiichi Sankyo, Inc. (Bernards, NJ)
- …periodic review for controlled proceduresEnsure global and cross-functional consistency of process documentation to the extent possible by coordinating reviews ... research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of process /equipment improvements and data trending/analysis Review/approval of completed process documentation Ability to train others on the manufacturing ... process and QMS systems Revise and create documentation (SOP, batch records, FT's) associated with the manufacture of product, requiring minimal direction Ability… more
- Raytheon (Mckinney, TX)
- …Process Control (SPC) and Design of Experiments (DOE) and writing shop process documentation . Developing and executing new product builds typically with ... world. We have an exciting opportunity for an SMT Process Engineer to join our Advanced Products Center (APC)...to join our Advanced Products Center (APC) RF Microelectronics Process Engineering team in McKinney, Texas. We are the… more
- Merck & Co. (Millsboro, DE)
- … documentation . Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel May be ... Lab Testing Equipment, Maintenance Processes, Mammalian Cell Culture, Management Process , Manufacturing Documentation , Manufacturing Operations, Manufacturing Quality… more
- Merck & Co. (Millsboro, DE)
- … documentation . Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel May be ... Information Management System (LIMS), Laboratory Maintenance, Maintenance Processes, Management Process , Manufacturing Documentation , Manufacturing Operations, Manufacturing Quality… more
- Raytheon (Andover, MA)
- …You Will DoTranslate engineering design requirements into formal manufacturing process documentation including raw material definition, fixturing/tooling ... added pay differential.Primary responsibilities include developing the comprehensive manufacturing process for 3D metal parts for various radar, integrated sensor,… more
- Merck & Co. (Rahway, NJ)
- …experience in conducting and directing the design, execution, analysis, and documentation of purification process development.Proven track record of ... -scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product documentation , inclusive of Design History, Product, ... Process and Service documentation in support of product realization and commercialization within the Beckman Coulter quality system.Awareness of current industry… more
- Eisai, Inc (NJ)
- …experience in the pharmaceutical industry, with in-depth knowledge of TMF process and clinical documentation and eTMF system management.Requirements Bachelor's ... globally. This role will identify, lead and participate in TMF system and process improvement initiatives, including SOP reviews, TMF reporting and serve as a… more
- AUROBINDO (Dayton, OH)
- …manufacturing/packaging procedures and federal regulations pertaining to manufacturing process .Experienced in proper documentation and correction practices.Read, ... and labeling material, water sampling, CV sampling, completion of appropriate documentation , registering in LIMS, deduction of sampling quantity in ERP, promptly… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …new/revised documents (to include change control, document creation, assessment of training/ documentation & routing/approval process ) Improve local change ... and training compliance at site Ensure local system and process is in place to ensure adequate training for...use of shop floor management tools (ie, problem solving, process mapping, value stream mapping and process … more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record ... for problem-solving and expertise in upstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist.BPR&D within Research… more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record ... -scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within… more
- Merck & Co. (Rahway, NJ)
- …and computational fluid dynamics.Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.Ability ... Job DescriptionThe Biologics Process Research & Development organization within our Company...supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing… more
- Aequor (Swiftwater, MN)
- …products, updating master data for new and existing analysis, maintaining system documentation , and providing ad hoc support to other departments. The position is ... timely resolution of technical - Responsible for the master data management process including the updating of specifications and supporting the approval process… more
- Repligen (Waltham, MA)
- OverviewWe are seeking motivated and experienced process engineer who will focus on multiproduct manufacturing support, project execution and tech transfer. The ... position is based in Waltham, MA and will be focused on process support & development for OPUS, ELISA and Affinity Ligand product lines. This individual will work… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …our cGMP commercial manufacturing facility. This role will work within our Process Engineering team focused on brownfield projects including: equipment upgrades, new ... to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions ... and validation activities of new equipment and systems, including documentation of IQ/OQ protocols, test executions, and summary reports...in design and hazard reviews of plant expansions or process changes and serving as the technical point of… more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience ... (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support… more
- Merck & Co. (Rahway, NJ)
- …DS processing (large molecule products) Lead planning, execution, analysis, and documentation of cell culture process commercialization Drive risk assessments, ... a culture of initiative, creativity, and problem-solving Deliver robust DS process and analytical strategies to enable successful commercialization Provide technical… more
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